Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

NCT04206384 | Completed Results FDA Device

• 1 other identifier: 005-00036-8
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness and safety of externally applied lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of fat cells/tissues below the skin, evidenced by a reduction in patient waist circumference.

Conditions

Abdominal Subcutaneous Fat

Keywords

Ultrasound; Low-Frequency

Outcome Measures

Primary Outcomes (1)

• Waist Circumference Change

  Change in measurable circumference of the patient's abdominal area from Baseline to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).

  The difference between the circumference measurement immediately prior to the first treatment (Baseline) to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).

Secondary Outcomes (1)

• Number of Participants With Pain

  Assessed during and immediately after (up to 15 minutes after use ceased) each application of the device, and at 1 week, 4 weeks, and 12 weeks post-treatment.

Study Arms (1)

Treatment group

EXPERIMENTAL

Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultimate Contour Body Sculpting Device

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or above 18
• Body Mass Index ≥ 25.

You may not qualify if:

• Age equal to or below 17.
• Body Mass Index \< 25.
• Open sores, wounds, or otherwise compromised skin in the treatment area
• History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing.
• Known or suspected pregnancy, or active nursing.
• General systemic conditions of arteriosclerosis, anemia, aortic aneurysm, or hypertension.
• Liver conditions such as hyperlipidemia, hepatitis, liver disease, or abnormal liver function.
• Diabetes or blood-glucose sensitivity
• Any prior invasive cosmetic surgery to the waist or abdominal area, such as liposuction.
• Hernias or diastasis recti within the treatment area.
• Concurrent, or within the last 6 months, participation in any clinical trial for another device or drug.
• Existing bacterial or viral infections (influenza, rhinovirus, hepatitis, pneumonia, tuberculosis, and the like)
• Presence of acne vulgaris, herpes zoster, psoriasis vulgaris, or similar skin conditions in the treatment area.
• Any type of cosmetic treatment to the target area within the last 6 months.
• Implanted active medical device anywhere in the subject, or metallic or polymeric implants in the vicinity of the treatment area.

Sponsors & Collaborators

• CAO Group, Inc.: lead

Study Sites (1)

Just the Right Cruves

Midvale, Utah, 84047, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

Due to the coronavirus (COVID-19) pandemic, the planned 12-week follow-up was conducted virtually. This prevented capture of the primary measurement at this timepoint.

Results Point of Contact

• Title: VP, Quality & Regulatory
• Organization: CAO Group

info@caogroup.com

801-256-9282

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Treatment Group

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: December 2, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 12, 2020
• Last Updated: August 23, 2021
• Results First Posted: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)